Download Guideline for Food Safety Assessment of Foods Derived from

Guideline for Food Safety Assessment of Foods
Derived from Genetically Modified Plants with
Stacked Traits
(Date: 2008-05-06)
(In case of any discrepancy between the Chinese text and the English
translation thereof, the Chinese text shall govern.)
I. This Guideline applies only to foods produced using genetically modified
plants with stacked traits obtained through conventional breeding between
genetically modified plants that are already approved.
II. Classification of genetically modified plants with stacked traits:
A) Category I: plants with two or more traits that are unrelated.
B) Category II: plants with two or more traits that are related but with different
modes of action.
C) Category III: plants with two or more traits that function in the same
biosynthetic pathway.
III. Food safety assessment of foods derived from genetically modified plants
with stacked traits belonging to category I and II.
A) The following bridging studies would need to be carried out to confirm that the
stacked product is derived from the combination by traditional breeding of the
single genetically modified events.
a. molecular characterization: a fingerprint-type Southern blot analysis, in
comparison to the parental lines;
b. information on the expression of new proteins: analysis of gene expression in
the stacked product to confirm that gene expression in relevant tissue(s) is
comparable to that in the single genetically modified events; and
c. compositional analysis and agronomic variables: the compositional and
agronomic analysis for the stacked product would be undertaken over a single
growing season (4 sites), and relevant comparisons would be made either with the
single-event genetically modified plants or with the non- genetically modified
control of comparable genetic background.
B) Protein safety evaluation and animal feeding studies would need to be
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conducted when necessary.
a. If no changes to protein mode of action can be expected in the stacked product,
no additional safety evaluation of the proteins and animal feeding studies would
be required.
b. If an interaction between the introduced proteins affecting their mode of action is
expected, the need for additional studies should be evaluated on a case-by-case
basis.
IV. Foods derived from genetically modified plants with stacked traits belonging to
category III are considered as new genetically modified foods. A complete food
safety assessment carried out in accordance with DOH guidelines is required.
V. Review process
Recognizing the rapid pace of development in the field of biotechnology, the
approach to food safety assessment of foods derived from modern biotechnology
should be reviewed when necessary to ensure that emerging scientific information
is incorporated into the risk analysis. When new scientific information relevant to a
risk assessment becomes available the assessment should be reviewed to
incorporate that information and, if necessary, risk management measures adapted
accordingly.
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